Recently, an inactivated vaccine (vero cell) against EV71 has been investigated in Phase 1 and Phase 2 clinical trials. Data from these trials showed that the EV71 vaccine has good safety profile and was immunogenic. 320 U alum-adjuvant vaccine has been chosen as the candidate vaccine for the phase 3 clinical trial.

This clinical trial is a supplementary phase 2 trial, which is designed to study the gene expression patterns induced by EV71 vaccine in Chinese healthy children aged from 2 to 5 years old use a systems biology approach combined with microarray analysis，RT-PCR and neutralizing antibody testing for PBMC and serum collected form the studied children population, to predict immunogenicity, and explore mechanistic insights about the EV71 vaccine.

Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws

Any acute infections in last 7 days

Any prior administration of immunodepressant or corticosteroids in last 6month

Any prior administration of blood products in last 3 month

Any prior administration of other research medicines in last 1month

Any prior administration of attenuated live vaccine in last 28 days

Any prior administration of inactivated vaccines in last 14 days, such as pneumococcal vaccine

Under the anti - TB prevention or therapy

Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679665